Reducing Time to Vaginal DeliveryPhase 3EXPEDITENCT01127581
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
A Phase 3 study testing MVI 200 and Dinoprostone Vaginal Insert (DVI) in people with Reducing Time to Vaginal Delivery and Cervical Ripening, run by Ferring Pharmaceuticals at 34 sites in United States.
Trial summary
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Reducing Time to Vaginal Delivery, Cervical Ripening, Induction of Labor
- What is being tested?
- MVI 200 and Dinoprostone Vaginal Insert (DVI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,358 participants
- Where
- 34 sitesUnited States
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent;
- Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
- Women aged 18 years or older;
- Candidate for pharmacological induction of labor;
- Single, live vertex fetus;
- Baseline modified Bishop score ≤ 4;
- Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
- Body Mass Index (BMI) ≤ 50 at the time of entry to the study.
Who cannot join
- Women in active labor;
- Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
- Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
- Fetal malpresentation;
- Diagnosed congenital anomalies, not including polydactyly;
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- Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
- Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
- Ruptured membranes ≥ 48 hours prior to the start of treatment;
- Suspected chorioamnionitis;
- Fever (oral or aural temperature > 37.5°C);
- Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
- Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
- Any condition urgently requiring delivery;
- Unable to comply with the protocol.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
University of New Mexico/New Mexico Health Science Center
Albuquerque, New Mexico
University of Michigan Hospital
Ann Arbor, Michigan
Medical University of South Carolina
Charleston, South Carolina
UT College of Medicine Chattanooga, Erlanger Health System
Chattanooga, Tennessee
University of Cincinnati
Cincinnati, Ohio
Duke University Medical Center
Durham, North Carolina
Clinical Trials of America
Eugene, Oregon
The Women's Clinic of Northern Colorado
Fort Collins, Colorado
Spectrum Health
Grand Rapids, Michigan
East Carolina University, Brody School of Medicine
Greenville, North Carolina
University Medical Group/Greenville Hospital System
Greenville, South Carolina
University of Texas Health Sciences Center at Houston
Houston, Texas
Indiana University School of Medicine
Indianapolis, Indiana
University of FL College of Medicine
Jacksonville, Florida
University of Kansas School of Medicine
Kansas City, Kansas
High Risk Obstetrical Consultants, PLLC
Knoxville, Tennessee
Altus Research
Lake Worth, Florida
Miller's Childrens Hospital
Long Beach, California
Marshfield Clinic Research Foundation
Marshfield, Wisconsin
Research Memphis Associates
Memphis, Tennessee
St. Peters University Hospital
New Brunswick, New Jersey
Christiana Care Health System (DE Center for MFM)
Newark, Delaware
UCI Medical Center
Orange, California
Drexel University College of Medicine
Philadelphia, Pennsylvania
Temple University School of Medicine
Philadelphia, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania
Maricopa Medical Center - District Medical Group
Phoenix, Arizona
Precision Trials
Phoenix, Arizona
Salt Lake Women's Center, PC
Sandy City, Utah
Phoenix Perinatal Associates (Scottsdale Healthcare Shea)
Scottsdale, Arizona
St. Louis University
St Louis, Missouri
University of South Florida
Tampa, Florida
Watching Over Mothers and Babies Foundation
Tucson, Arizona
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina
About this study
Official title: Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.
- Being tested
- MVI 200, Dinoprostone Vaginal Insert (DVI)
- Keywords
- Misoprostol vaginal insert, Dinoprostone vaginal insert, Cervidil, Cervical ripening, Induction of labor, Rate of cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVI 200Drug
Also called Misopess(TM), Misodel (R)
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Dinoprostone Vaginal Insert (DVI)Drug
Also called Cervidil (R), Propess (R)
Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
| Study group | Role | What they receive |
|---|---|---|
| MVI 200 | Experimental | MVI 200 mcg vaginal insert Receives: Drug: MVI 200 |
| Dinoprostone Vaginal Insert (DVI) | Active comparator | 10 mg Dinoprostone vaginal insert Receives: Drug: Dinoprostone Vaginal Insert (DVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Vaginal Delivery During the First Hospital Admission
Measured: Interval from study drug administration to vaginal delivery (average 24 hours)
Incidence of Cesarean Delivery During the First Hospital Admission
Measured: Interval from study drug administration to cesarean delivery (average 24 hours)
Secondary outcomes (9)
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission
Measured: Interval from study drug administration to neonate delivery (average 24 hours)
Time to Active Labor During the First Hospital Admission
Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.
Measured: Interval from study drug administration to active labor (average 12 hours)
Incidence of Pre-delivery Oxytocin During the First Hospital Admission
Percentage of participants in receipt of Oxytocin for induction after study drug removal.
Measured: At least 30 minutes after study drug removal
Incidence of Vaginal Delivery Within 12 Hours
Measured: Interval from study drug administration to vaginal delivery within 12 hours
Incidence of Any Delivery Within 24 Hours
Measured: Interval from study drug administration to delivery of neonate within 24 hours
Incidence of Any Delivery Within 12 Hours
Measured: Interval from study drug administration to delivery of neonate within 12 hours
Incidence of Vaginal Delivery Within 24 Hours
Measured: Interval from study drug administration to vaginal delivery within 24 hours
Incidence of Vaginal Delivery
Measured: Interval from study drug administration to vaginal delivery (average 24 hours)
Rate of Adverse Events
All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.
Measured: From study drug administration to hospital discharge (approximately 48-72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reducing Time to Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127581
- Sponsor's protocol ID
- Miso-Obs-303
- Acronym
- EXPEDITE
- Status last verified
- Apr 2014
- First submitted
- 19 May 2010
- Last updated
- 1 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Miller H, Goetzl L, Wing DA, Powers B, Rugarn O. Optimising daytime deliveries when inducing labour using prostaglandin vaginal inserts. J Matern Fetal Neonatal Med. 2016;29(4):517-22. doi: 10.3109/14767058.2015.1011117. Epub 2015 Mar 16.
PubMed 25758619Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2013 Aug;122(2 Pt 1):201-209. doi: 10.1097/AOG.0b013e31829a2dd6.
PubMed 23857539
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term
- ClinicalTrials.gov ID
- NCT01127581
- Acronym / sponsor ID
- EXPEDITE / Miso-Obs-303
- Keywords
- Misoprostol vaginal insert, Dinoprostone vaginal insert, Cervidil, Cervical ripening, Induction of labor, Rate of cesarean section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,358 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVI 200 | Experimental | Drug: MVI 200MVI 200 mcg vaginal insert |
| Dinoprostone Vaginal Insert (DVI) | Active comparator | Drug: Dinoprostone Vaginal Insert (DVI)10 mg Dinoprostone vaginal insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent;
- Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
- Women aged 18 years or older;
- Candidate for pharmacological induction of labor;
- Single, live vertex fetus;
Key exclusion criteria (15 listed)
- Women in active labor;
- Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
- Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
- Fetal malpresentation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVI 200Also: Misopess(TM), Misodel (R)Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | Drug | MVI 200 |
| Dinoprostone Vaginal Insert (DVI)Also: Cervidil (R), Propess (R)Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | Drug | Dinoprostone Vaginal Insert (DVI) |
Primary outcome
Time to Vaginal Delivery During the First Hospital Admission
Time frame: Interval from study drug administration to vaginal delivery (average 24 hours)
Incidence of Cesarean Delivery During the First Hospital Admission
Time frame: Interval from study drug administration to cesarean delivery (average 24 hours)
9 secondary outcomes
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission
Time frame: Interval from study drug administration to neonate delivery (average 24 hours)
Time to Active Labor During the First Hospital Admission
Time frame: Interval from study drug administration to active labor (average 12 hours)
Incidence of Pre-delivery Oxytocin During the First Hospital Admission
Time frame: At least 30 minutes after study drug removal
Incidence of Vaginal Delivery Within 12 Hours
Time frame: Interval from study drug administration to vaginal delivery within 12 hours
Incidence of Any Delivery Within 24 Hours
Time frame: Interval from study drug administration to delivery of neonate within 24 hours
Incidence of Any Delivery Within 12 Hours
Time frame: Interval from study drug administration to delivery of neonate within 12 hours
Incidence of Vaginal Delivery Within 24 Hours
Time frame: Interval from study drug administration to vaginal delivery within 24 hours
Incidence of Vaginal Delivery
Time frame: Interval from study drug administration to vaginal delivery (average 24 hours)
Rate of Adverse Events
Time frame: From study drug administration to hospital discharge (approximately 48-72 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25758619Miller H, Goetzl L, Wing DA, Powers B, Rugarn O. Optimising daytime deliveries when inducing labour using prostaglandin vaginal inserts. J Matern Fetal Neonatal Med. 2016;29(4):517-22. doi: 10.3109/14767058.2015.1011117. Epub 2015 Mar 16.
- Derived from this study: PubMed 23857539Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2013 Aug;122(2 Pt 1):201-209. doi: 10.1097/AOG.0b013e31829a2dd6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MVI 200 and Dinoprostone Vaginal Insert (DVI) in people with Reducing Time to Vaginal Delivery and Cervical Ripening, run by Ferring Pharmaceuticals at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Vaginal Delivery During the First Hospital Admission (time frame: Interval from study drug administration to vaginal delivery (average 24 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.